A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

Full Thickness Skin Defects Clinical Trial

Official title:

A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373566
• Other study ID #: ESG-NVM-II-2014
• Secondary ID: NL50542.094.14
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2020
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.

Description:

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years (for Zurich: = 18 years)

• Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm

• = 50% TBSA full thickness skin defects at time of intervention

• Informed consent by the patient and/or legal representatives.

Exclusion Criteria:

• Patients with infected wounds

• Full thickness skin wounds located in face and/or genitals will not be included

• Pregnant or breast feeding females

• Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)

• Known allergy against porcine collagen or elastin

• Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)

• Previous enrolment of the patient into the current study

Related Conditions & MeSH terms

• Full Thickness Skin Defects

Intervention

Device:
• Novomaix dermal substitute in combination with STSG
Novomaix dermal substitute in combination with STSG

Locations

Country	Name	City	State
Germany	Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie	Berlin
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland
Switzerland	Children's Hospital Department of Surgery Kinderspital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres	Ernst Reichmann Tissue Biology Research Unit, Zürich, Seventh Framework Programme

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

References & Publications (1)

Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Bühren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)	Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)	3 months post-operative
Secondary	Graft take (Subjective assessment by experienced observer)		5-7 days
Secondary	Epithelialisation (Subjective assessment by experienced observer)	Subjective assessment by experienced observer	5-7 days and 2-3 weeks post-operative
Secondary	Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)	Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire	12 months
Secondary	Scar quality (As determined with subjective scar assessment scale (POSAS)	As determined with subjective scar assessment scale (POSAS)	3 and 12 months
Secondary	Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)	As measured for scar colour and pigmentation using DSM II ColorMeter	3 and 12 months

External Links

•   euroskingraft results